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Re: DrRocker post# 126461

Thursday, 06/06/2013 6:03:46 PM

Thursday, June 06, 2013 6:03:46 PM

Post# of 345742

From FTM: "We know very little about the first-line trial.
We do not know anything about the patient characteristics. We do not even know what ECOG PS scores
are allowed. PS 0-2, or 0-1? The clinical trials webpage does not list this in the inclusion/exclusion criteria."


One key difference between the pending front-line trial where we are waiting on results and the old front line trial that showed a 20% improvement in Bavi treatment arm over an historical PC control arm, is that the pending 1st line trial excluded all squamous cell patients, which the earlier trial did not.

Maybe someone else can go back and look up how many squamous cell patients were in the old single arm trial. Squamous cell patients are much harder to treat, so there is a some basis for assuming the new data will show more than a 20% MOS improvement over the control arm.

Given that Avastin's front line trial back in 2006 reported only a 19.4% MOS improvement as compared to the PC control arm, with a 0.79 HR, Bavi has a fairly low bar to jump over to become the new SOC in front line given that Bavi's safety profile is so much better than Avastin.






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